HurriCaine

Product NDC: 0283-1016
11-digit product format: 002831016
Labeler code: 0283
Product ID: 0283-1016_259039d7-ae05-7abc-e063-6294a90af1fd
Type: HUMAN OTC DRUG
Nonproprietary name: BENZOCAINE
Dosage form: GEL
Route: DENTAL; ORAL; PERIODONTAL
Labeler: Beutlich Pharmaceuticals, LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-10-15
Substance: BENZOCAINE
Active strength: 200 mg/g
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: HurriCaine
Brand name suffix: Topical Anesthetic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOCAINE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
U3RSY48JW5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238910	Internal RxNorm lookup
996288	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0605d5d6-82bd-415e-b5cb-e273f934a4a7	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0283-1016-00	HurriCaineTopical Anesthetic	28.4 g in 1 BOTTLE, PLASTIC	GEL	28.4	45
0283-1016-31	HurriCaineTopical Anesthetic	1 in 1 BOX	GEL	1	45
0283-1016-43	HurriCaineTopical Anesthetic	1 g in 1 PACKET	GEL	1	45
0283-1016-45	HurriCaineTopical Anesthetic	0.5 g in 1 CUP, UNIT-DOSE	GEL	0.5	6
0283-1016-59	HurriCaineTopical Anesthetic	60 in 1 BOX	GEL	60	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0283-1016-31	GM - Gram	0283-1016	63b9ec1c-583b-4b8e-bdc3-b8b655959561	1	2018-05-09
0283-1016-45	EA - Each	0283-1016	8385d8b9-ec94-4266-84a9-7b44ed56fa24	1	2022-03-09
0283-1016-59	EA - Each	0283-1016	8952eeef-e587-474c-98cf-a7386719c335	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0283-1016	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	45	Current NDC, Legacy NDC, 3 package rows	20250110_42521b29-67e4-4a16-848d-7e6ba4a7ece2.zip
0283-1016	HURRICAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BEUTLICH PHARMACEUTICALS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241030_0605d5d6-82bd-415e-b5cb-e273f934a4a7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 11 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Crest Kids Advanced Color Changing	SODIUM MONOFLUOROPHOSPHATE	Procter & Gamble Manufactura, S de R.L. de C.V.	fc86b98e-d556-4769-e053-6394a90afc6e	2026-01-08	Warnings	Exact identifier application number: M022
Care One Maximum Strength	FLUORIDE	American Sales	1b6618ea-6533-41d7-be2c-13bb9e108dc5	2026-01-08	Warnings	Exact identifier application number: M022
equate Sensitive	POTASSIUM NITRATE, SODIUM FLUORIDE	Wal-Mart Stores Inc	79899b59-3a16-6504-e053-2991aa0a895a	2026-01-08	Warnings	Exact identifier application number: M022
Crest Kids Advanced Color Changing	SODIUM MONOFLUOROPHOSPHATE	Procter & Gamble Manufactura, S de R.L. de C.V.	451283d3-78b0-8361-e063-6294a90a1fd5	2026-01-08	Warnings	Exact identifier application number: M022
CVS Maximum Strength	BENZOCAINE	CVS Pharmacy	8691d6b6-741e-47b2-8332-76742b34715f	2026-01-08	Warnings	Exact identifier application number: M022
4x Medicated Toothache and Gum Gel	BENZOCAINE	Publix Super Markets INC	16eb9d15-dba3-36e6-e063-6394a90ab859	2026-01-08	Warnings	Exact identifier application number: M022
Toothache and Gum Relief	BENZOCAINE, MENTHOL	CVS Pharmacy	814ec7bf-f825-1095-e053-2a91aa0aee59	2026-01-08	Warnings	Exact identifier application number: M022
Lemon	GLYCERIN	Sion Biotext Medical Ltd	dbd7ed86-1b92-4471-827a-89f3afa1b0dc	2026-01-08	Warnings	Exact identifier application number: M022
Sootheez Organic Wild Cherry	PECTIN	BFY LLC	47baa2a8-270c-fa07-e063-6394a90a97f6	2026-01-06	Warnings	Exact identifier application number: M022
Parodontax Gum Strengthen and Protect	CETYLPYRIDINIUM CHLORIDE	Haleon US Holdings LLC	3bb378c8-14b2-aa13-e063-6294a90a4db3	2026-01-05	Warnings	Exact identifier application number: M022
MySweetSmile Toothpaste.	MYSWEETSMILE TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	478baf87-9276-7288-e063-6294a90a9e8e	2026-01-04	Warnings	Exact identifier application number: M022
MySweetSmile Mango Toothpaste.	MYSWEETSMILE MANGO TOOTHPASTE.	Jiangxi Dentalbright Technology Co., Ltd	478cbdeb-28e1-fa56-e063-6294a90af124	2026-01-04	Warnings	Exact identifier application number: M022
Smile Paint	SODIUM FLUORIDE	JABBER JAW KIDS TOOTHPASTE LLC	a7463b5c-53b2-4353-a5ea-800fbd7bd17d	2026-01-02	Warnings	Exact identifier application number: M022
Dentek Canker Cover	MENTHOL	Bershtel Enterprises	2669183c-7a58-037e-e054-00144ff88e88	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush strawberry	SODIUM FLUORIDE	Lander Enterprises, LLC	05929148-bffe-439f-a9d4-3170816c0fa2	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Watermelon	SODIUM FLUORIDE	Lander Enterprises, LLC	37a4e712-e3b5-42f6-971c-98dea4b8dd06	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Mint	SODIUM FLUORIDE	Lander Enterprises, LLC	6bcd35f5-18ea-4fc8-84cd-06db73f38a1e	2025-12-31	Warnings	Exact identifier application number: M022
AutoBrush Bubblegum	SODIUM FLUORIDE	Lander Enterprises, LLC	e7bf7e31-650d-4a1c-9100-48722344b201	2025-12-31	Warnings	Exact identifier application number: M022
Normal Salt	SODIUM CHLORIDE	GRAXCELL PHARMACEUTICAL, LLC	f3f09817-8a38-4aa1-956b-69d9cf695074	2025-12-25	Warnings	Exact identifier application number: M022
Sensitive Mint Tooth-paste	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer, Inc.	1e5e8b24-8304-482c-ae80-73effcc345da	2025-12-23	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U3RSY48JW5	BENZOCAINE	94-09-7	BENZOCAINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
238910	benzocaine 20 % Oral Gel	PSN	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
996288	HurriCaine 20 % Oral Gel	PSN	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
996288	Hurricaine 20 % Dental Gel	SY	42521b29-67e4-4a16-848d-7e6ba4a7ece2	45
238910	benzocaine 20 % Oral Gel	PSN	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
996288	HurriCaine 20 % Oral Gel	PSN	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
996288	benzocaine 0.2 MG/MG Oral Gel [Hurricaine]	SBD	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
238910	benzocaine 0.2 MG/MG Oral Gel	SCD	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
238910	benzocaine 20 % (180-220 MG per 1 GM) Oral Gel	SY	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
996288	Hurricaine 0.2 MG/MG Oral Gel	SY	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6
996288	Hurricaine 20 % Dental Gel	SY	0605d5d6-82bd-415e-b5cb-e273f934a4a7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0283-1016-00	00283101600	28.4 g in 1 BOTTLE, PLASTIC	28.4 g					Historical
0283-1016-31	00283101631	1 BOTTLE, PLASTIC in 1 BOX (0283-1016-31) / 28.4 g in 1 BOTTLE, PLASTIC (0283-1016-00)		2016-10-15	0000-00-00	No	No	Current
0283-1016-43	00283101643	1 g in 1 PACKET (0283-1016-43)	1 g	2020-01-28	0000-00-00	No	No	Current
0283-1016-45	00283101645	0.5 g in 1 CUP, UNIT-DOSE	0.5 g					Historical
0283-1016-59	00283101659	60 CUP, UNIT-DOSE in 1 BOX (0283-1016-59) / .5 g in 1 CUP, UNIT-DOSE (0283-1016-45)		2021-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SB Gel	Beutlich Pharmaceuticals, LLC \| Dental Technologies \| Speciality Pharma Manufacturing	2025-01-08	HUMAN OTC DRUG LABEL	45
SB Unit Dose Gel	Beutlich Pharmaceuticals, LLC \| Centrix Inc. \| Dental Technologies	2024-10-28	HUMAN OTC DRUG LABEL	6